Ranbaxy Launches ABSORICA® (isotretinoin) 25 mg and 35 mg Capsules in the U.S. Market

PRINCETON, N.J., Oct. 1, 2014 /PRNewswire/ -- Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), today announced the launch of ABSORICA^® (isotretinoin) 25 mg and 35 mg capsules into the U.S. healthcare market. ABSORICA has become the most prescribed branded oral isotretinoin in the U.S., as per a recent independent survey conducted with dermatologists. The product is licensed by Ranbaxy from Cipher Pharmaceuticals, Inc. It is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.

Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal, however, ABSORICA, which is formulated using patented Lidose™ technology, can be given without regards to meals. The fasted AUC_0-t of ABSORICA is approximately 83 percent greater than that of Accutane^®, while both products are bioequivalent under fed conditions. ABSORICA is therefore not interchangeable and not substitutable with generic products of Accutane^®.

Dr. Ashish Anvekar, Vice President of Brand Division North America, said, "Since isotretinoin dosing is weight-based, we are most pleased to make available these valuable, additional dosing options exclusively for ABSORICA. This will give prescribers the enhanced flexibility, to tailor the isotretinoin therapy depending on the patient's weight, and benefit the group of patients who are in that weight range, irrespective of their dietary intake. Ranbaxy continuously seeks to innovate and bring value based options to the specialty of dermatology and patients."

Please refer to the approved ABSORICA package insert for full prescribing information and dispensing instructions at http://www.absorica.com/

SAFETY NOTICE

Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking ABSORICA in any amount, even for a short period of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Because of the risk of teratogenicity and to minimize fetal exposure, ABSORICA is only available through a restricted distribution program called iPLEDGE™. Under this program, prescribers must be registered and activated with the iPLEDGE Program and can prescribe isotretinoin only to registered patients who meet all the requirements of the iPLEDGE Program. Isotretinoin can be dispensed only by a pharmacy registered and activated with the iPLEDGE Program. Registered and activated pharmacies can only receive isotretinoin from wholesalers registered with the iPLEDGE Program.

Some patients, while taking isotretinoin or soon after stopping isotretinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, "anxious" or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts), some have tried to end their own lives, and some have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. There have also been reports of psychotic symptoms, which indicate a loss of contact with reality. Psychotic symptoms include feelings of suspiciousness toward others, strange beliefs, hearing voices or other noises without an obvious source, and seeing unusual objects or people with no explanation. No one knows if isotretinoin caused these behaviors and symptoms or if they would have happened even if the person did not take isotretinoin. If any of these behaviors or symptoms occur, the patient should stop treatment and the patient or family member should contact the prescriber promptly without waiting until the next visit. Some people have had other signs of depression while taking isotretinoin.

Isotretinoin use has been associated with pseudotumor cerebri, a condition caused by increased pressure on the brain. This condition may occur more often in patients also taking tetracycline. Patients should be aware of other serious side effects, including problems with the skin, pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. The most common, less serious adverse events include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Patients should be advised about these adverse events and routinely monitored by a doctor during treatment with isotretinoin.

Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after isotretinoin treatment has been stopped.

About Ranbaxy Laboratories Inc.

Ranbaxy Laboratories Inc. (RLI), based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RLI is engaged in the sale and distribution of branded prescription products in the U.S. healthcare system.

About Ranbaxy Laboratories Limited

Ranbaxy Laboratories Limited (RLL) is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company's commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.com.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals (TSX: DND) is a growing specialty pharmaceutical company with three commercial products and a fourth in development, which are improved formulations of successful marketed drugs. We acquire products that fulfill high unmet medical needs, manage the required clinical development and regulatory approval process, and market those products either directly or through partners.

Our core capabilities include clinical and regulatory affairs, product licensing, supply chain management, and marketing and sales. Since the Company was founded in 2000, we have achieved regulatory marketing approval in the U.S. and Canada for all three of our original products and completed eight marketing partnerships, generating growing revenue streams and shareholder value.

Absorica is a registered trademark of Ranbaxy Laboratories Inc.
Lidose is a trademark of Galephar Pharmaceutical Research, Inc.
Accutane is a registered trademark of Hoffmann-La Roche Inc.
iPLEDGE is a registered trademark of McKesson Specialty Arizona, Inc.

SOURCE Ranbaxy Laboratories Inc.